ESC: Burned Again on Hot Line Research, ESC Regroups

STOCKHOLM -- Keeping "Hot Lines" hot continues to be a problem for the European Society of Cardiology where, for the second time in three days, the cat was out of the bag before the audience took its seats -- this time it was the results from EINSTEIN DVT, a trial of rivaroxaban (Xarelto) for secondary prevention of deep vein thrombosis.

Bayer, which is developing the drug, released top line results in early August, a move that the ESC initially considered a violation of its rules for Hot Line presentation that bar prior publication or release of research accepted for presentation as a Hot Line.

ESC program chair Fausto Pinto, MD, of the University of Lisbon, in Portugal, told MedPage Today that the ESC had initially decided to cancel the EINSTEIN DVT presentation, but "then we were advised by our lawyers that the company had an obligation to release the data, so we decided to go ahead with the presentation."

In a joint statement released this morning, the ESC and Bayer said the study results were "deemed to be materially important to Bayer AG and thus to have the potential to affect the publicly traded securities of the company. Because of this, Bayer had a legal obligation to initiate a predefined and formal process, which required it to notify the financial markets."

The statement also included this mea culpa from the drug maker: "Bayer recognises that it did not adequately discuss the situation with the ESC prior to issuing the 'ad hoc release' and has unreservedly apologised for this omission."

Still smarting from Monday's revelation that another Hot Line study had actually already been published in the European Journal of Heart Failure, Pinto acknowledged that the keeping Hot Lines "hot" is becoming more challenging.

To try to make the process more "responsive to the changing environment," he said the ESC plans to meet later this week to review Hot Line guidelines. And he said he plans to reach out to the American College of Cardiology and the American Heart Association so that "we can be united in our policies regarding late-breaking research."

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